eligibility_summary
Eligibility: >=65, consent, untreated transplant-ineligible symptomatic MM meeting CRAB/MDE, ECOG 0-2, life >=3 mo, oral meds, contraception, labs: ANC >=1.0, Plt >=50, Hgb >=80, AST/ALT <=1.5xULN, CrCl >=30. Exclude: prior MM therapy, dialysis, pregnancy, major CV risk/QTc >=470, neuropathy >=2, HIV/hepatitis, AL amyloidosis/PCL, chronic immunosuppression, strong CYP3A4 drugs, cannot use antithrombotics, recent COVID/surgery/live vaccine, active infection or malabsorption.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm, response-adapted trial in transplant‑ineligible newly diagnosed multiple myeloma. Regimen: Iberdomide (CC‑220, oral CELMoD small molecule) that binds cereblon to degrade Ikaros/Aiolos (IKZF1/3), suppressing IRF4/c‑MYC, directly inhibiting myeloma cells and activating T/NK cells, Bortezomib (subQ proteasome inhibitor) blocks the 26S proteasome, disrupts NF‑κB signaling, triggers ER‑stress apoptosis, Dexamethasone (oral glucocorticoid) induces lymphoid apoptosis and augments cytotoxicity. Isatuximab (subQ anti‑CD38 IgG1 mAb) is added on demand for suboptimal response (no VGPR by cycle 4 or MRD positive by cycle 8), it kills CD38+ myeloma via ADCC/CDC/ADCP and depletes CD38+ immunosuppressive cells. Targets: malignant plasma cells (CD38), cereblon–IKZF1/3–IRF4/c‑MYC axis, proteasome/ubiquitin pathway, engages T and NK effector pathways.